Status:
WITHDRAWN
Adhesive Materials for Continuous Glucose Monitoring Systems
Lead Sponsor:
Metronom Health
Collaborating Sponsors:
Medical University of Graz
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Within the present study 4 different band-aid/adhesive combinations will be tested in patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and allergic potential. The...
Eligibility Criteria
Inclusion
- Informed consent obtained after being advised of the nature of the study
- Male or female aged ≥18 years
- Type 1 diabetes for at least 6 months according to the WHO definition or Type 2 diabetes for at least 6 months according to the WHO definition
- Body Mass Index (BMI) \<45 kg/m²
- Willing and able to wear 4 different band-aid/adhesive materials for the duration of the study and undergo all study procedures
- HbA1c ≤86 mmol/mol
Exclusion
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- Any mental condition rendering the subject incapable of giving his consent
- Subject is using any medication that significantly impacts immune response (oral steroids)
- Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- Subject is actively enrolled in another clinical trial
- Known severe hypersensitivity to adhesive or skin lesions that hinder band-aid application
- Inability of the subject to comply with all study procedures
- Inability of the subject to understand the subject information
- Has children two years of age or younger
- Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law).
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03340467
Start Date
August 1 2018
End Date
September 30 2018
Last Update
August 19 2019
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